Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects "Apply Shift" and presses Motion Enable buttons. This can result in the actual patient position differing from that position indicated by the imaging application affecting position accuracy and precision.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

NY, Switzerland

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PRODUCT

Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism. Recall # Z-0107-2011

The recall was initiated after Beckman Coulter confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA assay may not be achieved for lot numbers: 891198, 990980 and 991448. The kit lot numbers listed above passed the stability testing performed at 6 months, but failed the testing performed at 12 months. Therefore the affected I-PTH ELISA kit lots may produce falsely elevated patient results. These lots may also produce elevated results on quality control materials provided by other manufacturers. Internal stability testing showed an average 57% elevation.

in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001). The in2it (I) is for Physician use, the (II) is for prescription home use. The products are medical devices used in affinity chromatography method, intended for the in-vitro quantitative determination of A1c (HbA1C) in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall glycemic control. Recall # Z-0109-2011

Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the unlikely event that this sequence occurs, all subsequent high voltage therapies will experience prolonged charge time or loss of high voltage therapy (due to a charge circuit timeout). Device alerts are nominally ON and will notify patients to seek medical attention should either of these alert conditions occur.

VOLUME OF PRODUCT IN COMMERCE

143,900 implanted

DISTRIBUTION

Nationwide and Internationally

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PRODUCT

GE Centricity Laboratory Instrument Interface software. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. Recall # Z-0123-2011

During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.

VOLUME OF PRODUCT IN COMMERCE

1,608,067 sets

DISTRIBUTION

Nationwide, Canada, Japan, Australia, New Zealand, and Chile

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PRODUCT

Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. Recall # Z-0159-2011

CODE

Sequencer for MOSAIQ 1.60W3 (including all service packs), 2.00T2 (including all service packs), 2.10L5 (including all service packs) and 2.10M7 (including all service packs)

Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.

An increase in voltage may cause a short circuit of a power transistor that may cause a smoldering and smoking effect of the electrical wiring and also an unexpected lowering of the Table. Both issues present the potential for injury to a patient or the operator.

The spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position.